Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function

May 20, 2024 updated by: Muhammad Naveed Babur, Superior University

Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function

Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • The University of Lahore Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 45-65 years old (Jeong et al., 2019)
  • Both genders will be included (Jeong et al., 2019)
  • Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
  • Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)

Exclusion Criteria:

  • Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
  • Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
  • Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
  • Neurological conditions affecting leg function (Peterson et al., 2022)
  • Pregnancy (Jeong et al., 2019)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)
Diagnostic test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)

Side-lying clamshells: 3 sets of 10 repetitions per leg, 3 times per week Hip abduction with theraband: 3 sets of 10 repetitions per leg, 3 times per week Bridge with hip abduction: 3 sets of 10 repetitions per leg, 3 times per week

Electrical muscle stimulation:

Applied to the gluteus medius and minimus muscles for 20 minutes per session, 3 times per week Frequency and intensity adjusted to individual tolerance
Other: Conservative Treatment (CT)
Other: Conservative Treatment (CT)
Stretching: Iliotibial band stretch: 30-second hold, 3 repetitions per leg, 2 times per day Quadriceps stretch: 30-second hold, 3 repetitions per leg, 2 times per day Hamstring stretch: 30-second hold, 3 repetitions per leg, 2 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measured using a numeric pain rating scale (NPRS)
Time Frame: 12 Months
ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up.
12 Months
Lower Extremity Functional Scale (LEFS)
Time Frame: 12 months
Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up
12 months
ITBT length
Time Frame: 12 months
Measured using a goniometer at baseline, after intervention, and at 1-month follow-up.
12 months
Range of motion (ROM):
Time Frame: 12 months
Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up."
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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